Preview

Опухоли женской репродуктивной системы

Расширенный поиск

Гормонотерапия больных метастатическим раком молочной железы в пременопаузе: комбинации с ингибиторами циклинзависимых киназ

https://doi.org/10.17650/1994-4098-2019-15-2-30-41

Полный текст:

Аннотация

В статье обсуждаются вопросы поиска наиболее эффективных стратегий терапии гормонозависимого HER2-отрицательного метастатического рака молочной железы в пременопаузе. До недавнего времени выключение яичников и последовательная гормонотерапия были основным видом лечения пациенток этой подгруппы. Появление палбоциклиба, названного «терапией прорыва», и впечатляющие результаты добавления ингибиторов циклинзависимых киназ 4 и 6 (CDK4/6) к режимам гормонотерапии у больных в менопаузе привели к необходимости оценки эффективности и безопасности данной стратегии в комбинации с овариальной супрессией у молодых пациенток.

Как показали результаты рандомизированных исследований и подгрупповых анализов, добавление ингибитора CDK4/6 к овариальной супрессии и гормональному препарату в соответствующей линии терапии приводит к существенному увеличению показателей выживаемости. Данные по безопасности соответствуют таковым у пациенток старшей возрастной группы. Рандомизированное исследование по сравнению комбинации палбоциклиб + овариальная супрессия + ингибитор ароматазы с химиотерапией у больных в пременопаузе показало достоверное превосходство новой стратегии: назначение ингибитора CDK4/6 в составе комплексного режима на 36 % снизило риск прогрессирования по сравнению с капецитабином.

Об авторах

Е. В. Артамонова
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России
Россия

Елена Владимировна Артамонова 

115478 Москва, Каширское шоссе, 24



Е. И. Коваленко
ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России
Россия
115478 Москва, Каширское шоссе, 24


Список литературы

1. Bray F., Ferlay J., Soerjomataram I. et al. Global Cancer Statistics 2018: GLOBO-CAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68(6):394–424. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx.

2. Злокачественные новообразования в России в 2015 г. (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой. М., 2017.

3. Siegel R.L., Miller L.D., Jemal A. Cancer Statistics 2018. CA Cancer J Clin 2018;68(1):7–30. DOI: 10.3322/caac.21442.

4. Злокачественные заболевания в России в 2016 г. (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой. М., 2018. 250 c.

5. Anders C.K., Hsu D.S., Broadwater G. et al. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol 2008;26(20):3324–30. DOI: 10.1200/JCO.2007.14.2471.

6. Chen H., Zhou M.-Q., Tian W. et al. Effect of age on breast cancer patient prognoses: A Population-Based Study Using the SEER 18 Database. PLoS One 2016;11(10):e0165409. DOI: 10.1371/journal.pone.0165409.

7. Cardoso F., Sencus E., Costa A. et al. 4 th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC4). Ann Oncol 2018;(29):1634–57.

8. Rugo H.S., Rumble R.B., Macrae E. et al. Endocrine therapy for hormone receptorpositive metastatic breast cancer: Americane Society of Clinical Oncology guideline. JCO 2016. DOI: 10.1200/JCO.2016.67.1487.

9. Wilcken N., Hornbuckle J., Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev 2003;(2):CD002747.

10. Cardoso F., Senkus E., Costa A. et al. 4 nd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC4). Ann Oncol 2018;29:1634–57.

11. Noguchi S., Kim H.J., Jesena A. et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer 2016;23(5):771–9.

12. Masuda N., Iwata H., Rai Y. et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat 2011;126(2):443–51.

13. Cardoso F., Loibl S., Pagani O. et al. The European Society of Breast Cancer Specialists recommendations for the management of young women with breast cancer. Eur J Cancer 2012;48(18):3355–77.

14. Partridge A.H., Pagani O., Abulkhair O. et al. First international consensus guidelines for breast cancer in young women (BCY1). Breast 2014;23(3):209–20.

15. Christinat A., Di Lascio S., Pagani O. Hormonal therapies in young breast cancer patients: when, what and for how long? J Thorac Dis 2013;5(suppl 1):S36–46.

16. Llombart-Cussac A., Pivot X.B., Biganzoli L. et al. A prognostic factor (PF) index for overall survival in a HER2-negative endocrine-resistant metastatic breast cancer (MBC) population: Analysis from the ATHENA trial. ASCO 2013. J Clin Oncol 2013;31(suppl):abstr.555.

17. Cardoso F., Costa A., Norton L. et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol 2014;25(10): 1871–88.

18. Finn R.S., Crown J.P., Lang I. et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/ TRIO-18): a randomised phase 2 study. Lancet Oncol 2015;16(1):25–35.

19. Finn R.S., Crown J.P., Ettl J. et al. Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: expanded analyses of subgroups from randomized pivotal trial PALOMA-1/TRIO-18. Breast Cancer Res 2016;18:67. DOI: 10.1186/s13058-016-0721-5.

20. Finn R.S., Crown J.P., Lang I. et al. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer (PALOMA-1; TRIO-18). JCO 2017;35(suppl):abstr.1001.

21. Finn R.S., Martin M., Rugo H.S. et al. Palbociclib and letrozole in advanced breast cancer. NEJM 2016;375:1925–36.

22. Finn R.S., Dieras V., Rugo H.S. et al. Palbociclib (PAL) + letrozole (L) as first-line (1L) therapy (tx) in estrogen receptor-positive (ER + )/human epidermal growth factor receptor 2-negative (HER2 – ) advanced breast cancer (ABC): efficacy and safety across patient (pt) subgroups. JCO 2017;35(suppl):abstr.1039.

23. Rugo H.S., Finn R.S., Dieras V. et al. Palbociclib (PAL) + Letrozole (LET) As First-Line Therapy in Estrogen Receptor-Positive (ER + )/Human Epidermal Growth Factor Receptor 2-Negative (HER2 − ) Advanced Breast Cancer (ABC): Efficacy and Safety Updates With Longer Follow-Up Across Patient Subgroups. Presented at 2017 San Antonio Breast Cancer Symposium, December 5–9, 2017; San Antonio, Texas. Abstr. P5-21-03.

24. Hortobagyi G.N., Stemmer S.M., Burris H.A. al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375:1738–48.

25. Hortobagyi G.N., Stemmer S.M., Burris H.A. et al. Updated results from MONALEESA-2, a phase 3 trial of first-line ribociclib + letrosol in hormone receptor-positive (HR + ), human epidermal growth factor receptor 2-negative (HER2 – ) advanced breast cancer (ABC). ASCO 2017 (abstr. 1038).

26. Hortobagy G.N. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 Trial. Breast Cancer Res 2018;20:123.

27. Yardley D. et al. SABCS 2018, abstr. P6-18-07.

28. Tripathy D., Sohn J., Im S.-A. et al. First-line ribociclib or placebo combined with goserelin and tamoxifen or non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the randomized phase III MONALEESA-7 trial. Presented at 2017 San Antonio Breast Cancer Symposium; December 5–9, 2017; San Antonio, Texas. Abstr. GS2-05.

29. Yardley D.A., Chan A., Nusch A. et al. Ribociclib + endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: subgroup analysis of phase III MONALEESA trials. Presented at San Antonio Breast Cancer Symposium; December 4–8, 2018; San Antonio, Texas. Abstr. 1000.

30. Beck J.T., et al. Ribociclib treatment benefit in patients with advanced breast cancer > 1 dose reduction: data from the MONALEESA-2, -3 and -7 trials. San Antonio Breast Cancer Symposium; December 4–8, 2018. Poster P6-18-06.

31. Tripathy D., Im S.A., Colleoni M. et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol 2018;19(7):904–15. DOI: 10.1016/S1470-2045(18)30292-4.

32. Hurvitz S.A., Im S.-A., Lu Y.-S.H. et al. Phase III MONALEESA-7 trial of premenopausal patients with HR + /HER2 – advanced breast cancer (ABC) treated with endocrine therapy + ribociclib: Overall survival (OS) results. ASCO 2019. Abstr. LBA 1008. Available at: https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.18_suppl.LBA1008.

33. Cristofanilli M., Turner N.C., Bondarenko I. et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016;17:425–39.

34. Turner N.C., Jiang Y., O’Leary B. et al. Efficacy of palbociclib plus fulvestrant (P+F) in patients (pts) with metastatic breast cancer (MBC) and ESR1 mutations (mus) in circulating tumor DNA (ctDNA). J Clin Oncol 2016;34(suppl);abstr.512.

35. Harbeck N., Iyer S., Cristofanilli M. et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol 2016;27:1047–54.

36. Turner N.C., Slamon D.J., Ro J. et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med 2018;379:1926–36.

37. Loibl S., Turner N.C., Ro J. et al. Palbociclib combined with fulvestrant in premenopausal women with advanced breast cancer and prior progression on endocrine therapy: PALOMA-3 results. Oncologist 2017;22(9):1028–38.

38. Neven P., Rugo H.S., Tolaney S.M. et al. Abemaciclib for pre/perimenopausal women with HR + , HER2-advanced breast cancer. ASCO 2018. Abstr. 1002.

39. Francis P., Regan M., Fleming G. San Antonio Breast Cancer Symposium (SABCS): abstr. S3-08. Presented December 11, 2014.

40. Klijn J.G.M., Beex L.V., Mauriac L. et al. Combined treatment with buserelin and tamoxifen in premenopausal metastatic breast cancer: A randomized study. J Natl Cancer Inst 2000;92:903–11.

41. Dowsett M., Doody D., Miall S. et al. Vorozole results in greater oestrogen suppression than formestane in postmenopausal women and when added to goserelin in premenopausal women with advanced breast cancer. Breast Cancer Res Treat 1999;56:25–34.

42. Early Breast Cancer Trialists’ Collaborative Group. Ovarian ablation in early breast cancer: Overview of the randomised trials. Lancet 1996;348:1189–96.

43. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effects of chemo-therapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687–717.

44. Dowsett M., Lønning P.E., Davidson N.E. Incomplete estrogen suppression with gonadotropin-releasing hormone agonists may reduce clinical efficacy in premenopausal women with early breast cancer. J Clin Oncol 2016;34(14):1580–3.

45. Dowsett M., Jacobs S., Aherne J. et al. Clinical and endocrine effects of leuprorelin acetate in pre- and postmenopausal patients with advanced breast cancer. Clin Ther 1992;14(suppl A):97–103.

46. Klotz L., Boccon-Gibod L., Shore N.D. et al. The efficacy and safety of degarelix: A 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int 2008;102:1531–8.

47. Dowsett M., Folkerd E., Doody D. et al. The biology of steroid hormones and endocrine treatment of breast cancer. Breast 2005;14:452–7.

48. Walker K.J., Walker R.F., Turkes A. et al. Endocrine effects of combination antioestrogen and LH-RH agonist therapy in premenopausal patients with advanced breast cancer. Eur J Cancer Clin Oncol 1989;25:651–4.

49. Dowsett M., Stein R.C., Coombes R.C. Aromatization inhibition alone or in combination with GnRH agonists for the treatment of premenopausal breast cancer patients. J Steroid Biochem Mol Biol 1992;43:155–9.

50. Dowsett M., Doody D., Miall S. et al. Vorozole results in greater oestrogen suppression than formestane in postmenopausal women and when added to goserelin in premenopausal women with advanced breast cancer. Breast Cancer Res Treat 1999;56:25–34.

51. Casper R.F., Mitwally M.F.M. Review: aromatase inhibitors for ovulation induction. J Clin Endocrinol Metab 2006;91:760–71.

52. Smith I.E., Dowsett M., Yap Y.S. et al. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: Caution and suggested guidelines. J Clin Oncol 2006;24:2444–7.

53. Rossi E., Morabito A., de Maio E. et al. Endocrine effects of adjuvant letrozole + triptorelin compared with tamoxifen + triptorelin in premenopausal patients with early breast cancer. J Clin Oncol 2008;26:264–70.

54. Bellett M., Gray K.P., Francis P.A. et al. Twelve-month estrogen levels in premeno-pausal women with hormone-receptor positive breast cancer receiving adjuvant triptorelin plus exemestane or tamoxifen in the SOFT trial: The SOFT-EST substudy. J Clin Oncol 2016;34(14):1584–93. DOI: 10.1200/JCO.2015.61.2259.

55. Pfeiler G., Konigsberg R., Filipcic L. et al. Follicle-stimulating hormone (FSH) as a surrogate parameter for the effectiveness of endocrine therapy with or without zoledronic acid in premenopausal patients with breast cancer: An analysis of the prospective ABCSG-12 trial. J Clin Oncol 2014;32:(suppl 24s):abstr.577.

56. Thomas E.J., Walton P.L., Thomas N.M. et al. The effects of ICI 182,780, a pure anti-oestrogen, on the hypothalamic-pituitary-gonadal axis and on endometrial proliferation in premenopausal women. Hum Reprod 1994;9:1991–6.

57. Young O.E., Renshaw L., Macaskill E.J. et al. Effects of fulvestrant 750 mg in premenopausal women with oestrogen-receptor-positive primary breast cancer. Eur J Cancer 2008;44:391–9.

58. Park Y.H., Kim T.-Y., Kim G.M. et al. A ramdomized phase II study of palbociclib plus exemestane with GnRH agonist versus capecitabine in premenopausal women with hormone receptor-positive metastatic breast cancer (KCSG-BR 15-10, NCTO 2592746). ASCO 2019. Abstr. 1007.


Для цитирования:


Артамонова Е.В., Коваленко Е.И. Гормонотерапия больных метастатическим раком молочной железы в пременопаузе: комбинации с ингибиторами циклинзависимых киназ. Опухоли женской репродуктивной системы. 2019;15(2):30-41. https://doi.org/10.17650/1994-4098-2019-15-2-30-41

For citation:


Artamonova E.V., Kovalenko E.I. Hormone therapy for premenopausal women with metastatic breast cancer: combinations with cyclin-dependent kinase inhibitors. Tumors of female reproductive system. 2019;15(2):30-41. (In Russ.) https://doi.org/10.17650/1994-4098-2019-15-2-30-41

Просмотров: 187


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1994-4098 (Print)
ISSN 1999-8627 (Online)